Nuvation Bio’s IBTROZI™ Wins Regulatory Approval in Japan for Advanced ROS1-Positive Non-Small Cell Lung Cancer
Nuvation Bio Inc. (NYSE: NUVB), a global oncology company dedicated to developing novel therapies for some of the most challenging cancers, announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has officially approved IBTROZI™ (taletrectinib) for the treatment of adult patients with ROS1-positive (ROS1+) unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC). This decision marks another important regulatory milestone for the company, further expanding access to a therapy that has been described as a potential best-in-class option for this subset of lung cancer patients.
Under the terms of an exclusive license agreement signed in 2023, Nuvation Bio granted Nippon Kayaku Co., Ltd. commercialization rights for IBTROZI in Japan. With MHLW approval secured, Nippon Kayaku will now be responsible for launching the drug in the Japanese market, a significant step given Japan’s growing incidence of lung cancer and strong emphasis on precision oncology.
Approval Backed by TRUST Clinical Program
The approval of IBTROZI in Japan is supported by robust data from the pivotal Phase 2 TRUST program, which evaluated taletrectinib in patients across several countries, including Japan. TRUST was designed to assess both efficacy and safety in patients with ROS1+ NSCLC, whether newly diagnosed or previously treated.
A pooled analysis of TRUST program results was published in the Journal of Clinical Oncology in April 2025, highlighting the clinical potential of taletrectinib as a next-generation ROS1 inhibitor. The findings reinforced that the therapy demonstrated significant activity in both treatment-naïve patients and those who had already received ROS1 tyrosine kinase inhibitors (TKIs). Importantly, it also showed activity against common resistance mutations and central nervous system (CNS) metastases, both of which represent major unmet needs in lung cancer care.
Companion Diagnostic Approval
Alongside the approval of IBTROZI, Japan’s MHLW also cleared the AmoyDx® PLC Panel as a companion diagnostic. This diagnostic tool will be used to identify patients with locally advanced or metastatic ROS1+ NSCLC who are eligible for treatment with IBTROZI. Companion diagnostics are a critical component of precision oncology, ensuring that the right patients receive targeted therapies that are most likely to be effective for their tumor profiles.
Building a Global Footprint for IBTROZI
Nuvation Bio emphasized that this Japanese approval builds on recent major regulatory achievements worldwide.
- United States Approval (June 2025): On June 11, 2025, the U.S. Food and Drug Administration (FDA) granted full approval to IBTROZI for the treatment of locally advanced or metastatic ROS1+ NSCLC across all lines of therapy. This approval followed a Priority Review and recognition of taletrectinib with two Breakthrough Therapy Designations, reflecting its potential to transform care for ROS1-positive lung cancer patients.
- NCCN Guidelines Recognition: Just nine days later, on June 20, 2025, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancers to include taletrectinib (IBTROZI) as a Preferred Agent. This recommendation applied to both first-line and subsequent therapy, with explicit guidance for patients presenting with brain metastases and for those whose tumors harbor resistance mutations—two key areas where effective treatment options remain limited.
- China Approval (January 2025): Earlier in the year, on January 6, 2025, the National Medical Products Administration (NMPA) in China approved taletrectinib for adults with locally advanced or metastatic ROS1+ NSCLC, regardless of prior exposure to ROS1 TKIs. In China, the drug is marketed under the brand name DOVBLERON® by Innovent Biologics, Nuvation Bio’s regional partner.
These global approvals underscore the company’s strategic approach to advancing IBTROZI as a truly international therapeutic option for patients with ROS1+ NSCLC.
CEO Perspective on the Approval
David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, expressed his enthusiasm regarding the MHLW decision:
Building on the regulatory approvals for IBTROZI in the U.S. and China, this additional approval by the MHLW further underscores the best-in-class potential and promise that IBTROZI holds for patients living with advanced ROS1-positive non-small cell lung cancer around the globe. We remain steadfastly committed to bringing forward innovative cancer treatments that can help patients stay ahead of their disease.”
Dr. Hung highlighted the approval as a validation of Nuvation Bio’s global development strategy and its dedication to improving outcomes for patients facing difficult-to-treat cancers.
Financial Milestone Linked to Japan Launch
Commercialization in Japan also carries financial significance for Nuvation Bio. Once the reimbursement price for IBTROZI is established—expected in the fourth quarter of 2025—the company will receive a $25 million milestone payment. This payment will contribute to the continued advancement of Nuvation Bio’s pipeline and portfolio, helping the company sustain momentum across its broader oncology development programs.
The Unmet Need in ROS1+ NSCLC
Non-small cell lung cancer remains the most common type of lung cancer, representing around 85% of all cases globally. Within this population, approximately 1–2% of patients harbor a ROS1 gene rearrangement, a rare but important molecular driver.
Patients with ROS1+ NSCLC often face unique treatment challenges. While first-generation ROS1 inhibitors have been available, resistance frequently develops, and many therapies struggle to adequately treat brain metastases—a common complication in lung cancer. The ability of IBTROZI to address both resistance mutations and CNS involvement distinguishes it as a promising next-generation therapy, offering hope for improved long-term outcomes.
Nuvation Bio’s Strategic Collaborations
The journey of taletrectinib from development to approval has been enabled by strategic partnerships. In Japan, Nippon Kayaku’s role will be crucial in ensuring successful commercialization, physician engagement, and patient access. In China, Innovent Biologics has already introduced DOVBLERON® to the market, providing valuable real-world insights into adoption and use.
These partnerships allow Nuvation Bio to leverage local expertise while maintaining global oversight of IBTROZI’s rollout, ensuring consistency in clinical messaging and brand positioning.
With approvals now in the United States, China, and Japan, IBTROZI is rapidly establishing itself as a cornerstone therapy in the management of ROS1+ NSCLC. Nuvation Bio is expected to continue working with regulators in additional regions, potentially extending access to Europe and other parts of Asia in the near future.
The company also remains committed to exploring taletrectinib’s potential in other oncogenic-driven cancers beyond NSCLC, an area of ongoing preclinical and clinical research.
The approval of IBTROZI™ (taletrectinib) in Japan by the MHLW marks another significant chapter in Nuvation Bio’s mission to redefine treatment for difficult-to-treat cancers. Backed by strong clinical evidence, recognition in major oncology guidelines, and growing global adoption, IBTROZI is positioned to become a standard of care for patients with ROS1-positive NSCLC.
As commercialization efforts move forward in Japan with Nippon Kayaku, and with milestone payments set to fuel further innovation, Nuvation Bio continues to demonstrate its ability to execute on a global scale. For patients with ROS1+ NSCLC—particularly those with resistance mutations or brain metastases—this approval represents more than regulatory progress; it represents renewed hope for longer, healthier lives.
